Initial evaluation rate invariance for Alzheimer’s Disease drug trials after first appointment modification

IF 11.1 1区 医学 Q1 CLINICAL NEUROLOGY Alzheimer's & Dementia Pub Date : 2025-01-09 DOI:10.1002/alz.092240
Ralph Lee, Yu-Jay Huoh, Brenda Martinez, Elly Lee
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Abstract

Background

Recruiting large numbers of study participants for Alzheimer’s Disease (AD) drug trials remains a significant challenge in need of more effective approaches. Advertising can be an effective way to reach large numbers of prospective participants, but can suffer from low attendance rates. This study examined the relationship between the initial behaviors of prospective AD trial participants who did not attend their first scheduled appointment and their overall likelihood of eventually attending an in-person consultation.

Method

In 2023, 4,043 potential participants were identified through online advertising and scheduled for 5,561 appointments for an in-person pre-screen at a commercial research site. Only 45.0% attended their first scheduled appointment. In lieu of attending their first scheduled appointment, 32.3% (n = 1,307) called in to the clinic to modify (i.e. cancel or reschedule) their first scheduled appointment and the remaining 22.7% (n = 915) simply did not attend their first scheduled appointment. Recruiters attempted to reschedule the latter group for another appointment.

Result

Of the 4,043 potential participants who were ever scheduled for an in-person pre-screen, 55.8% of these participants eventually attended an appointment, whether during the first or subsequently scheduled appointments.

Of the 1,307 potential participants who called in to modify their first scheduled appointment, 506 of these potential participants were scheduled for a subsequent appointment, with 57.3% of these persons eventually attending. This deviation from the 55.8% overall attendance rate is not statistically significant (p = 0.50).

However, of the 915 potential participants who simply did not attend their first scheduled appointment, 352 were scheduled for a subsequent appointment. Of these 352, only 43.5% eventually attended an appointment. This deviation from both the overall attendance rate and the attendance rate for those who modified their first appointment were highly significant (p < 1e-4 for both).

Conclusion

Potential AD trial participants who modify their first appointment are adequately engaged in the process, and so not attending their first appointment does not adversely affect their chances of attending a pre-screen. In contrast, potential participants who simply do not show up are much less likely to ever attend any appointment (almost 25% relative, >13% absolute).

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第一次预约修改后阿尔茨海默病药物试验的初始评价率不变
背景:招募大量研究参与者进行阿尔茨海默病(AD)药物试验仍然是一个重大挑战,需要更有效的方法。广告是吸引大量潜在参与者的有效方式,但可能会受到低出席率的影响。本研究考察了未参加第一次预约的潜在AD试验参与者的初始行为与最终参加亲自咨询的总体可能性之间的关系。2023年,通过在线广告确定了4043名潜在参与者,并安排了5561次预约,在商业研究站点进行现场预筛选。只有45.0%的人在首次预约时到场。32.3% (n = 1,307)的患者没有参加首次预约,而是打电话到诊所更改(即取消或重新安排)他们的首次预约,其余22.7% (n = 915)的患者根本没有参加他们的首次预约。招聘人员试图将后者重新安排到另一个约会。结果:在4043名曾经被安排进行现场预筛选的潜在参与者中,55.8%的参与者最终参加了预约,无论是在第一次还是随后的预约中。在1,307名致电更改首次预约的潜在参与者中,有506名潜在参与者被安排参加后续预约,其中57.3%的人最终参加了预约。这个偏离55.8%的总出勤率在统计上不显著(p = 0.50)。然而,在915名根本没有参加第一次预约的潜在参与者中,352名被安排参加随后的预约。在这352人中,只有43.5%的人最终赴约。这种偏离总体出勤率和修改第一次预约的出勤率是非常显著的(p <;两者都是e-4)。潜在的AD试验参与者修改了他们的第一次预约,充分参与了这一过程,因此不参加他们的第一次预约并不会对他们参加预筛查的机会产生不利影响。相比之下,根本不出现的潜在参与者参加任何预约的可能性要小得多(几乎是25%的相对比例,13%的绝对比例)。
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来源期刊
Alzheimer's & Dementia
Alzheimer's & Dementia 医学-临床神经学
CiteScore
14.50
自引率
5.00%
发文量
299
审稿时长
3 months
期刊介绍: Alzheimer's & Dementia is a peer-reviewed journal that aims to bridge knowledge gaps in dementia research by covering the entire spectrum, from basic science to clinical trials to social and behavioral investigations. It provides a platform for rapid communication of new findings and ideas, optimal translation of research into practical applications, increasing knowledge across diverse disciplines for early detection, diagnosis, and intervention, and identifying promising new research directions. In July 2008, Alzheimer's & Dementia was accepted for indexing by MEDLINE, recognizing its scientific merit and contribution to Alzheimer's research.
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